Title: Metrologist

Job Summary

Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at URL Pharma, including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

CORE VALUES

Integrity

Ability to follow policies/practices and make good morale decisions in everyday life. Demonstrating superior honesty, fairness, and discretion based on a very high ethical and prudent moral character from a personal, organizational, and social perspective. Complying established policies, practices, and internal value system to ensure all actions are in line with the organization’s ethical standards.  Recognizing the impact of unfavorable ethical acts and goes out of the way to ensure behavior is unquestionable to represent the organization well. 

Caring/Collaborative Teamwork

Soliciting and sharing ideas, providing respective input and support. Consistently fostering collaboration and respect among all stakeholders (inside and community) by asking/ensuring that all feedback is heard and addressed within the group channels to help everyone collectively reach their goals.  Demonstrating “role model” behavior utilizing a high level of enthusiasm, commitment, and interpersonal skills to drive goals through collaborative synergies.  Communicating in a clear, friendly, respectful business-standard way to create positive relationships and interaction between both internal/external customers.

Innovation

Quickly learning the background, details, and processes to create quality work on time.  Researching, analyzing, and creating enhancements for area of responsibility that creates demonstrable impact to the goals. Networking with individuals for continual feedback and input to reflect and stretching thinking that creates synergies and enhanced ideas for stronger outcomes.

Continuous Improvement

Continually researching new techniques and development opportunities to enhance current skill sets in the areas of dress, communications, presentation skills, and technical performance.  Providing recommendations on trends related to the area that may be transferable to other areas of the organization on an on-going basis. Willingly putting in extra time and effort in crisis situations; goes the “extra mile” to ensure goal is met.  Getting job done efficiently. 

Accountability/Ownership

Taking ownership of the aligned goals and areas of responsibility to ensure objectives are fully met. Making themselves available to others and follows up, as needed, for mutual goal-attainment.  Setting enhanced objectives for self to continually challenge the organization to rise to new heights. Demonstrating optimal inclusiveness and seeking diverse approaches/input on an on-going basis.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but is not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date.
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Qualifications

  • Associate’s degree (A. A.) or equivalent from technical school; Bachelor’s degree in Engineering or Chemistry is preferred
  • Two to four years related experience and/or training; or equivalent combination of education and experience
  • Calibration/Maintenance/Service certifications in lab equipment are required
  • Extensive Calibration/Maintenance/Repair experience on various lab instruments required
  • Minimum 2 – 4 years experience of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred
  • Previous experience in the pharmaceutical industry highly desirable
  • Must have good communication and technical writing skills
  • Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required.
  • Physical Demands

Physical Demands

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, color vision and depth perception.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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